Electroretinogram and Retinal Vascular Changes After Cataract Surgery

Primary Open Angle Glaucoma Clinical Trial

Official title:

Changes of Electrophysiology and Optical Coherence Tomography Angiography in Primary Open Angle Glaucoma After Phacoemulsification

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05871034
• Other study ID #: SAHASSAN
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2023
• Source: Sohag University
• Contact: shorouq abdelrahman
• Phone: 01016685915
• Email: shorouqabdelrahman2015[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare electrophysiological and Optical coherence tomography angiography of optic disc and macula changes after uneventful phacoemulsification between normal and cataractus patients with primary open angle glaucoma.

Description:

• Study design: A prospective, non randomized, interventional, comparative study, control based study.

• Location: Ophthalmology department, Sohag university hospital. In this prospective study, aiming to investigate Optical coherence tomography angiography and electrophysiological changes after cataract surgery in normal and patients with POAG with cataract 1 day before operation, 1 week and 3 months postoperatively.

• Methodology The study will include 50 patients with primary open angle glaucoma associated with cataract and 50 patients have cataract without glaucoma.

Preoperative and postoperative evaluation:

All patients will be subjected to the following:

• History taking including age, gender, family history, systemic diseases, previous medications or ophthalmic surgery.

• Detailed ophthalmological examination including: Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA) by Snellen's fraction and converted into logarithm of the minimal angle of resolution LogMAR, refraction, keratometry, slit lamp biomicroscopy for anterior segment, IOP measurement by applanation tonometer, and posterior segment (Fundus) examination.

• Examination of the angle of anterior chamber by goniolens.

• OCTA disc and macula

• Pattern ERG and multifocal ERG

Surgical techniques:

Patients will be subdivided into two groups:

Group (A): normal Patients will undergo standard phacoemulsification surgery. Group (B):

Patients with POAG will undergo standard phacoemulsification surgery.

• phaco technology by using (WHITESTAR SIGNATURE PRO, Abbott, USA)

• OCT angiography will be done by (Optovue, Inc., Fremont, California, USA).

• Electrophysiology will be done by (Roland consult Retimap, Germany)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients aged: 45-65 years old with cataract density doesn't interfere with Pre-operative imaging (N1-N2).

• Patients with primary open angle diagnosed for at least 2 years with glaucoma treatment associated with cataract (N1-N2).

Exclusion criteria:

s? patient with PACG.

• Previous intraocular surgery.

• Associated ocular or intra ocular inflammation

• Previous history of eye trauma.

• Associated intraocular pathology

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Procedure:
• phacoemulsification
cataract extraction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern and multifocal electroretinogram and Optical coherence tomography angiography of optic disc and macula changes after phacoemulsification in primary open angle glaucoma	electrophysiology and optical coherence tomography angiography changes	before operation and 1st month, 3rd month post operative
Secondary	Visual acuity and intra ocular pressure changes	visual acuity and intraocular pressure changes	before operation and 1st month, 3rd month post operative